By Development, and Translation Forum on Drug Discovery, Institute of Medicine
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Additional info for Addressing the Barriers to Pediatric Drug Development: Workshop Summary
Krogstad, F. T. Aweeka, and Pediatric AIDS Clinical Trials Group 377 Protocol Team. 2003. Nelfinavir pharmacokinetics in stable human immunodeficiency virus-positive children: Pediatric AIDS Clinical Trials Group Protocol 377. Pediatrics 112:e220–e227. ICH (International Conference on Harmonization). 2000. ICH harmonised tripartite guideline: Clinical investigation of medicinal products in the pediatric population E11. Current Step 4 version dated 20 July 2000. org/LOB/media/MEDIA487. pdf (accessed January 22, 2007).
Nelson, ethical barriers to the study of pediatric drugs fall into four categories: • Clinicians are willing to prescribe drugs off label without sufficient pediatric data (adults, of course, are prescribed drugs off label as well). This willingness to use drugs without sufficient data results in delays in needed research. • Sponsors, as expected, act in their financial self-interest. They often pursue pediatric clinical trials late in a drug’s life cycle, after its true market value has been determined.
A closed IRB system. A transparent system would allow the public to be informed about the substance of the decisions made, not just the decision process. The public would also know of failures and delays by the industry in investigating or publishing information on adverse events In closing, Dr. Nelson suggested that the ethical principles mentioned above pose barriers not to the responsible conduct of appropriately designed pediatric studies, but to studies that should not be conducted. The barriers that exist to appropriate studies may instead arise from a reluctance to alter existing practices and focus on the goal of finding efficient and effective ways to develop adequately studied drugs for the treatment of children.